APEX
FDA 510(k) clearance K111676 · decided 2011-09-30
Clearance details
- K-number
- K111676
- Device name
- APEX
- Applicant
- Elekta Limited
- Decision
- Substantially Equivalent
- Date received
- 2011-06-15
- Decision date
- 2011-09-30
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- IXI
- Device class
- 2
- Regulation number
- 892.5710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- West Sussex, GB
- Third-party review
- No
- Expedited review
- No
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